Vitilimus Ointment 30gm1 pc
Vitilimus ® Tacrolimus
Vitilimus 0.03% Ointment : Each gram ointment contains Tacrolimus Monohydrate INN equivalent to Tacrolimus 0.3mg
Vitilimus 0.1% Ointment : Each gram ointment contains Tacrolimus Monohydrate INN equivalent to Tacrolimus 1mg
Adults and adolescents (16 years of age and above): Treatment of moderate to severe atopic dermatitis in adults who are not
adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in
patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial
response to a maximum of 6 weeks treatment of twice daily Vitilimus (Tacrolimus) ointment (lesions cleared, almost cleared or
Dosage and administration
Vitilimus (Tacrolimus) ointment can be used for short-term and intermittent long-term treatment. Treatment should not be
continuous on a long-term basis. Vitilimus (Tacrolimus) treatment should begin at the first appearance of signs and symptoms. Each
affected region of the skin should be treated with Vitilimus (Tacrolimus) until lesions are cleared, almost cleared or mildly
affected. Thereafter, patients are considered suitable for maintenance treatment. At the first signs of recurrence (flares) of the
disease symptoms, treatment should be re-initiated. Adults and adolescents (16 years of age and above): Treatment should be
started with Vitilimus (Tacrolimus) 0.1% ointment twice a day and treatment should be continued until clearance of the lesion.
If symptoms recur, twice daily treatment with Vitilimus (Tacrolimus) 0.1% should be restarted. An attempt should be made to reduce
the frequency of application or to use the lower strength Vitilimus (Tacrolimus) 0.03% ointment if the clinical condition allows.
Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of
treatment, further treatment options should be considered.
Elderly patient: Specific studies have not been conducted in elderly patients. However, the clinical experience available in this
patient population has not shown the necessity for any dosage adjustment.
Pediatric population: Only Vitilimus (Tacrolimus) 0.03% ointment should be used in children from the age of 2 to 16 years.
Vitilimus (Tacrolimus) ointment should not be used in children aged below 2 years until further data are available.
Patients who are responding to up to 6 weeks treatment using Vitilimus (Tacrolimus) ointment twice daily (lesions cleared, almost
cleared or mildly affected) are suitable for maintenance treatment. Adults and adolescents (16 years of age and above): Adult
patients (16 years of age and above) should use Vitilimus (Tacrolimus) 0.1% ointment. Vitilimus (Tacrolimus) ointment should be
applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression
to flares. Between applications there should be 2-3 days without Vitilimus (Tacrolimus) treatment. After 12 months treatment, a
review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance
treatment in the absence of safety data for maintenance treatment beyond 12 months. If signs of a flare reoccur, twice daily
treatment should be re-initiated.
Elderly patients: Specific studies have not been conducted in elderly patients. Paediatric population: Only Vitilimus (Tacrolimus)
0.03 % ointment should be used in children from the age of 2 to 16 years. Vitilimus (Tacrolimus) ointment should not be used in
children aged below 2 years until further data are available.
Method of administration:
Vitilimus (Tacrolimus) ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Tacrolimus
ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Tacrolimus
ointment should not be applied under occlusion because this method of administration has not been studied in patients.
Contra-indications, warnings, etc.
Contra-indications: Vitilimus (Tacrolimus) ointment is contra-indicated to known hypersensitivity to Tacrolimus, macrolides in
general, or to any of the excipients. Warning and precautions: Exposure of the skin to sunlight should be minimized and the use of
ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use
of Tacrolimus ointment. Physicians should advise patients on appropriate sun protection methods, such as minimization of the time
in the sun, use of a sunscreen product and covering of the skin with appropriate clothing. Tacrolimus ointment should not be
applied to lesions that are considered to be potentially malignant or pre-malignant. The development of any new change different
from previous eczema within a treated area should be reviewed by the physician. The use of Tacrolimus ointment is not recommended
in patients with a skin barrier defect. These skin conditions may increase systemic absorption of Tacrolimus. Oral use of
Tacrolimus is also not recommended to treat these skin conditions. Post-marketing cases of increased Tacrolimus blood level have
been reported in these conditions. Care should be exercised if applying Tacrolimus to patients with extensive skin involvement
over an extended period of time; especially in children. Patients, particularly paediatric patients should be
continuously evaluated during treatment with Tacrolimus with respect to the response to treatment and the continuing need for
treatment. After 12 months this evaluation should include suspension of Tacrolimus treatment in paediatric patients. The potential
for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of
years) is unknown. Vitilimus ointment contains the active substance Tacrolimus, a calcineurin inhibitor. In transplant patients,
prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been
associated with an increased risk of developing lymphomas and skin malignancies. In patients using Tacrolimus ointment, cases of
malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers have been
reported. Tacrolimus should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that
cause immunosuppression. Patients with atopic dermatitis treated with Tacrolimus have not been found to have significant systemic
Tacrolimus levels. Lymphadenopathy was uncommonly (0.8%) reported in clinical trials. The majority of these cases were related to
infections (skin, respiratory tract, and tooth) and resolved with appropriate antibiotic therapy. Transplant patients receiving
immunosuppressive regimens (e.g. systemic Tacrolimus) are at increased risk for developing lymphoma; therefore patients
who receive Tacrolimus and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy
resolves. Lymphadenopathy present at initiation of therapy should be investigated and kept under review. In case of
persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated. In the absence of a clear aetiology for
the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Tacrolimus should be
considered. Tacrolimus ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic
dermatitis. Before commencing treatment with Tacrolimus ointment, clinical infections at treatment sites should be cleared.
Patients with atopic dermatitis are predisposed to superficial skin infections. Treatment with Tacrolimus may be associated with
an increased risk of folliculitis and herpes viral infections. In the presence of these infections, the balance of risks
and benefits associated with Tacrolimus use should be evaluated. Emollients should not be applied to the same area within 2 hours
of applying Tacrolimus ointment. Concomitant use of other topical preparations has not been assessed. There is no experience
with concomitant use of systemic steroids or immunosuppressive agents. Care should be taken to avoid contact with eyes and
mucous membranes. If accidentally applied to these areas, the ointment should be thoroughly wiped off and/or rinsed off with
water. The use of Tacrolimus ointment under occlusion has not been studied in patients. Occlusive dressings are not recommended.
As with any topical medicinal product, patients should wash their hands after application if the hands are not intended for
treatment. Tacrolimus is extensively metabolized in the liver and although blood concentrations are low following topical therapy,
the ointment should be used with caution in patients with hepatic failure. Drug interactions: Formal topical drug interaction
studies with Tacrolimus ointment have not been conducted. Tacrolimus is not metabolised in human skin, indicating that there is
no potential for percutaneous interactions that could affect the metabolism of Tacrolimus. Systemically available Tacrolimus is
metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4). Systemic exposure from topical application of Tacrolimus ointment is low
(< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4. However, the
possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g.
erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done
with caution. Use in Pregnancy: There are no adequate data from the use of Tacrolimus ointment in pregnant women. Studies in
animals have shown reproductive toxicity following systemic administration. The potential risk for humans is unknown. Tacrolimus
ointment should not be used during pregnancy unless clearly necessary. Use in lactation: Human data demonstrate that, after
systemic administration, Tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure
from application of Tacrolimus ointment is low, breast-feeding during treatment with Tacrolimus ointment is not recommended.
Side effects: pplication-site reactions including rash, irritation, pain and paraesthesia; herpes simplex infection;
application-site infections (with preventative therapy); less commonly acne; rosacea and skin malignancy also reported. Overdose:
Overdosage following topical administration is unlikely. If ingested, general supportive measures may be appropriate. These may
include monitoring of vital signs and observation of clinical status. Due to the nature of the ointment vehicle, induction of
vomiting or gastric lavage is not recommended.
Store in a cool & dry place, protected from light.
Vitilimus 0.03% Ointment: Carton containing 30g ointment in alu tube.
Vitilimus 0.1% Ointment: Carton containing 30g ointment in alu tube.